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The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.
The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Cementless Medial Partial Knee | ||
| Control | Cemented Medial Partial Knee |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects) | Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects | 22+months |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship (Cementless Only) | Minimum 1,000 cases to assess survivorship of cementless components | 22+ Months |
| American Knee Society Score | Assessment of Function and Range of Motion; retrospective study- data will be collected if available |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 362 cases (121 investigational cases and 241 control cases) for primary efficacy and safety assessment (Primary Comparative Analysis Group); and exploratory assessment from one center in England.
A total of approximately 1,000 investigational cases for "survivorship only" assessment from three centers.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. David Murray, BA Hons, BChir, FRCS, MD | Nuffield Orthopaedic Centre | Principal Investigator |
| Prof. Hemant Pandit, MBBS, MS, DNB, FRCS, DPhil | Nuffield Orthopaedic Centre | Study Director |
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The primary analysis data is patient level data; collected in anticipation of potential PMA submission.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 0-16 Week, 6 Month, 12 Month |
| Oxford Knee Score | Retrospective study; data will be collected if available. | 0-16 Weeks, 6 Months, 12 Months, 22+ Months |
| Adverse Events | Through 22+ Months Postop |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |